Efficacy of Potassium Sodium Hydrogen Citrate Therapy on Renal Stone Recurrence and/or Residual Fragments After Shockwave Lithotripsy and Percutaneous Nephrolithotomy in Calcium Oxalate Urolithiasis

This study has been completed.
ChaingMai University
Prince Songkla University
Chulalongkorn University
Siriraj Hospital
Information provided by:
Ouiheng International Healthcare Co., Ltd
ClinicalTrials.gov Identifier:
First received: April 4, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
Extracorporeal shock wave lithotripsy (ESWL) and Percutaneous nephrolithotomy (PCNL) become the therapy of choice for renal stone. Although providing good results, stone recurrence is usually found as the therapies do not change the underlying metabolic abnormality. Among the metabolic disorders, hypocitraturia is an important risk factor for calcium nephrolithiasis. This study evaluate the preventive effects of potassium sodium citrate on stone recurrence as well as stone growth post ESWL or PCNL, in patients with calcium-containing stones.

Condition Intervention Phase
Kidney Calculi
Drug: Potassium-sodium citrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Ouiheng International Healthcare Co., Ltd:

Primary Outcome Measures:
  • rate of stone recurrence or stone growth [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The patients were evaluated at 6 months after the initial treatment for serum chemistry and urinalysis. After 12 months, all patients were evaluated for serum chemistry, urinalysis, 24-hour urine study and plain KUB.

Enrollment: 80
Study Start Date: May 2005
Study Completion Date: February 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Potassium-sodium citrate
    The treated group was given oral potassium-sodium citrate 81 mEq/day The control group received no treatment
    Other Name: Uralyt-U

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • age > 18 years
  • stone free or had residual calcium oxalate stone fragments with a less than 4 mm. diameter at eight weeks after ESWL or PCNL

Exclusion Criteria:

  • renal tubular obstruction
  • serum creatinine > 2 mg/dl
  • urinary tract infection (bacteria > 100,000 in urine culture)
  • hypersensitive or contraindication to Potassium sodium hydrogen citrate
  • insertion Double-J Stent
  • history of arrhythmia, myocardial infarction or digitalis administration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329042

Sponsors and Collaborators
Ouiheng International Healthcare Co., Ltd
ChaingMai University
Prince Songkla University
Chulalongkorn University
Siriraj Hospital
Principal Investigator: Bannakij Lojanapiwat, MD Division of Urology, Department of Surgery, Chiangmai University, Thailand
  More Information

Responsible Party: Bannakij Lojanapiwat, Division of urology, Department of surgery, Chiangmai University, Thailand
ClinicalTrials.gov Identifier: NCT01329042     History of Changes
Other Study ID Numbers: UU01/47 
Study First Received: April 4, 2011
Last Updated: April 4, 2011
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Ouiheng International Healthcare Co., Ltd:
Potassium sodium citrate
stone recurrence

Additional relevant MeSH terms:
Kidney Calculi
Kidney Diseases
Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Citric Acid
Calcium Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Sequestering Agents

ClinicalTrials.gov processed this record on May 26, 2016